Trial · NCT02305654
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | up to 5 years | The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up. |
| Secondary | Disease specific survival time | up to 5 years | Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death. |
| Secondary | Number of patients experience a grade 3 or 4 toxicity | up to 5 years | |
| Secondary | Disease-free survival time | up to 5 years | Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation. Subsidiary outcome measures will be * locoregional recurrence free survival time (LRFST). * distant metastases free survival time (DMFST). * A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation. |
| Secondary | Occurrence of surgical complication | up to 5 years | |
| Secondary | Is it possible to achieve pathological nodal assessment after chemotherapy | 12 weeks | Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy. |
| Secondary | Quality of life | Baseline, 3, 6, 9, 12, 18, 24 and 36 months | Measured using the EORTC-QLQC30 and Lymphodema-QL |
| Secondary | Occurrence of Pathological complete remission | Time to complete remission after randomisation | Measured for all patients in InPACT-neoadjuvant: Absolute absence of disease on histological examination |
| Secondary | Operability | 2-6 weeks | Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur. |
| Secondary | Occurrence of Lower limb/scrotal oedema | up to 5 years | Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema |
| Secondary | On-schedule delivery of neoadjuvant therapy | After randomisation up to 12 weeks | Feasibility of on-schedule delivery of neoadjuvant therapy |
| Other | Acceptability of randomisation | up to 5 years | In addition to the outcome measures, the acceptability of both randomisations will be monitored based on the proportion of eligible patients approached for randomisation, the proportion of approached patients consenting to randomisation and the proportion of randomised patients receiving their allocated treatment. This will provide ongoing information regarding the feasibility of the trial successfully completing to target. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02305654/registered